UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010517 |
|---|---|
| Receipt number | R000012276 |
| Scientific Title | Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy |
| Date of disclosure of the study information | 2013/04/19 |
| Last modified on | 2018/05/05 17:12:15 |
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Basic information
Public title
Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Acronym
Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Scientific Title
Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Scientific Title:Acronym
Interfractional displacement and variation of prostate during multifractionated high-dose-rate interstitial brachytherapy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to measure prostate displacement and valiation during the treatment of high dose rate interstitial brachytherapy by CT, and to establish the best optimization protocol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The displacement measurement of the applicator for the marker in the prostate during the prostatic monotherapy period.
Key secondary outcomes
Evaluation of the change of DVH of OAR and CTV with the displacement.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Measure the displacement of needle applicator according to the gold marker inserted in prostate by CT during high dose rate interstitial monothreapy treatment period
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
*Histologically proven prostate cancer
*Any Gleason Score
*Any pretreatment PSA
*Any T stage
*Clinicaly diagnosed as N0M0 with MRI, bone scan, CT and so on.
*Use UICC TNM2009 for staging.
*ECOG performance status 0 or 1.
*Blood test results are compatible with criterias as below.
WBC>=3000/ul, Hb>=10.0g/dl, Plt>=100000/ul, Cre>=2.0 mg/dl, GOT>=100U/L, GPT<=100U/L
*Without any history of local therapy such as operation, trans-urethral procedure, hyperthermia. Hormonal therapy is permitted.
*Informed concented cases.
Key exclusion criteria
*Case having an active synchronous double cancer.
*Case having an uncontrollable diabetes .
*Case having a complication that doesn't quit internal use of anticoagulant.
*Case having a serious cranial nerve disease
*Case having collagenosis
*The case that the examination medical attendant judged to be inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Yoshioka |
Organization
Osaka University Graduate School of Medicine
Division name
Radiation Oncology
Zip code
Address
2-2 D10, Yamadaoka, Suita
TEL
06-6879-3482
yoshioka@radonc.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Suzuki |
Organization
Osaka University Graduate School of Medicine
Division name
Radiation Oncology
Zip code
Address
2-2 D10, Yamadaoka, Suita
TEL
06-6879-3482
Homepage URL
osamu-s@umin.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Dept of Radiation Oncology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 17 | Day |
Last modified on
| 2018 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012276
